Drug product
IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
D-585-2013
Product summary
- Firm
- Pentec Health
- Event
- Event 65180
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 Bags
- Official record key
drug-enforcement:D-585-2013
Official wording
Reason: Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Code information: Compounding Date: a) 04/25/13, b) 04/24/13 Discard After: a) 05/20/13, b) and c) 05/15/13
Distribution pattern: Dialysis Centers Direct to patient
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility